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Medical device recalls: April 2005

The FDA posted 119 medical device recall records in April 2005, from 49 recall events by 32 companies. 119 have not been classified yet.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

  1. Diasorin Inc. · 12 events, 12 records
  2. Baxter Healthcare Corp. · 3 events, 5 records
  3. Cryolife Inc · 3 events, 5 records
  4. Cincinnati Sub-Zero Products Inc · 2 events, 2 records
  5. Philips Medical Systems Sales & Service Region No. America · 2 events, 2 records
  6. Ethicon Endo-Surgery · 1 event, 36 records
  7. MMS Sales Corp · 1 event, 9 records
  8. Bard Access Systems, Inc · 1 event, 7 records

FDA root cause

  1. Other · 116
  2. Labeling False and Misleading · 2
  3. Software design · 1

Not yet classified (119)

The FDA has posted these records but has not published a class for them yet.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.